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Treatment Study Comparing Medium or High Dose Uva-1 Treatment 3x/Week Versus Fluocinonide 0.05% Cream in the Treatment of Morphea.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by University of Texas Southwestern Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00812188
First received: December 18, 2008
Last updated: December 19, 2008
Last verified: September 2008
History of Changes
  Purpose

Compare UVA-1 phototherapy treatment to topical steroid treatment in subjects with morphea.


Condition Intervention
Symmetric Limited Morphea.
 Other: Medium Dose UVA-1
Other: High Dose UVA-1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Open Label Trial of High Dose UVA-1, 3x/Week or Medium Dose UVA-1, 3x/Week vs. Fluocinonide 0.05% Cream Treatment of Morphea

Resource links provided by NLM:

MedlinePlus related topics: Scleroderma
U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Efficacy of UVA-1 treatment vs. topical steroid. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: November 2004
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Medium Dose UVA-1
Medium dose (60 J/cm2) UVA-1 3x/week for 12 weeks to one morphea plaque and fluocinonide 0.05% cream to another morphea plaque twice daily for twelve weeks.
 Other: Medium Dose UVA-1
UVA-1 phototherapy treatment (60 J/cm2) three times per week for 12 weeks.
Active Comparator: High Dose UVA-1
High dose UVA-1 treatment 3x/week for 12 weeks to one morphea plaque and fluocinonide 0.05% cream twice daily for 12 weeks to another morphea plaque.
 Other: High Dose UVA-1
High dose (120 J/cm2)UVA-1 phototherapy three times per week for 12 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects 18 years of age or older.
  • Symmetric limited morphea.

Exclusion Criteria:

  • Known sensitivity to fluocinonide 0.05% cream.
  • Clinical evidence of superinfected skin.
  • Immunocompromised state (including previously documented HIV).
  • Generalized Scleroderma.
  • Previous history of skin cancer.
  • Non-English speaking subjects.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812188

Locations
United States, Texas
UT Southwestern Medical Center at Dallas - Department of Dermatology Clinical Trials
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Heidi Jacobe, M.D. UT Southwestern Medical Center at Dallas
  More Information

No publications provided

Responsible Party: Heidi Jacobe, M.D. - Assistant Professor of Dermatology, UT Southwestern Medical Center at Dallas
ClinicalTrials.gov Identifier: NCT00812188     History of Changes
Other Study ID Numbers: 112004027
Study First Received: December 18, 2008
Last Updated: December 19, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Texas Southwestern Medical Center:
Morphea
Plaque morphea
Localized Scleroderma

Additional relevant MeSH terms:
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases
Fluocinonide
Glucocorticoids
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Allergic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013